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Personal Lubricant

by Shenzhen Huanqiu Xuebao Technology Co., Ltd.

510(k) K210857

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210857 Date24 Sep 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NUC
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Personal Lubricant is a medical device classified as a lubricant for personal use. It is a water-based formulation intended for penile and/or vaginal application to moisturize and lubricate, enhance ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.

The device is supplied non-sterile and is intended for single-use. It is compatible with natural rubber latex and polyisoprene condoms. The product received FDA 510(k) clearance (K210857) on September 24, 2021, and is classified as a Class II device under regulation number 884.5300 with product code NUC.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Personal Lubricant intended for?

    Personal Lubricant is intended for penile and/or vaginal application to moisturize and lubricate, enhance ease and comfort of intimate sexual activity, and supplement the body's natural lubrication, as stated in the device description.

  • How is Personal Lubricant supplied and is it sterile or single-use?

    Personal Lubricant is supplied non-sterile and is intended for single-use, meaning it should be used once and then discarded, as specified in the device description.

  • Is Personal Lubricant compatible with condoms?

    Yes, Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms, which is explicitly mentioned in the device description.

  • What regulatory clearance does Personal Lubricant have?

    Personal Lubricant received FDA 510(k) clearance (K210857) on September 24, 2021, and is classified as a Class II device under regulation number 884.5300 with product code NUC, as stated in the device data.